High Pressure Tubing, Keep™
25 catalogue numbers from 00884450568637, listed by Merit Medical Systems, Inc., United States, under Tubing, Fluid Delivery. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
25catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | FPK |
| Device type | Tubing, Fluid Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-02-18 |
| Record revised | 2025-03-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 25, pack of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450568637 | Tubing Length (in/cm)-20″ (51 cm) | In distribution |
| 00884450569160 | Tubing Length (in/cm)-48″ (122 cm) | In distribution |
| 00884450046135 | Tubing Length (in/cm)-60″ (152 cm) | In distribution |
| C | Tubing Length (in/cm)-30″ (76 cm) | In distribution |
| 00884450006948 | Tubing Length (in/cm)-20″ (51 cm) | In distribution |
| 00884450387672 | Pressure Rating psi (bar)-1200 psi (83 bar) | In distribution |
| 00884450006931 | Pressure Rating psi (bar)-1200 psi (83 bar) | In distribution |
| B | Pressure Rating psi (bar)-1200 psi (83 bar) | In distribution |
| 00884450387719 | Pressure Rating psi (bar)-1200 psi (83 bar) | In distribution |
| 00884450387634 | Tubing Length (in/cm)-48″ (122 cm) | In distribution |
| 00884450387696 | Pressure Rating psi (bar)-1200 psi (83 bar) | In distribution |
| 00884450387559 | Pressure Rating psi (bar)-1200 psi (83 bar) | In distribution |
| 00884450027967 | Pressure Rating psi (bar)-1200 psi (83 bar) | In distribution |
| B | Pressure Rating psi (bar)-1200 psi (83 bar) | In distribution |
| 00884450027950 | Pressure Rating psi (bar)-1200 psi (83 bar) | In distribution |
| B | Pressure Rating psi (bar)-1200 psi (83 bar) | In distribution |
| B | Tubing Length (in/cm)-30″ (76 cm) | In distribution |
| 00884450008034 | Tubing Length (in/cm)-72″ (183 cm) | In distribution |
| 00884450021439 | Pressure Rating psi (bar)-1200 psi (83 bar) | In distribution |
| 00884450006924 | Pressure Rating psi (bar)-1200 psi (83 bar) | In distribution |
| 00884450387665 | Tubing Length (in/cm)-60″ (152 cm) | In distribution |
| 00884450046142 | Tubing Length (in/cm)-60″ (152 cm) | In distribution |
| 00884450027974 | Tubing Length (in/cm)-72″ (183 cm) | In distribution |
| 00884450568705 | Pressure Rating psi (bar)-1200 psi (83 bar) | In distribution |
| 00884450568651 | Tubing Length (in/cm)-20″ (51 cm) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| High Pressure Tubing | Merit Medical Systems, Inc. | 68 |
| Vygon | Vygon Corp. | 67 |
| Medex | ICU Medical, Inc | 41 |
| Pressure Monitor Tubing | Merit Medical Systems, Inc. | 21 |
| Medrad® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in) | Bayer Medical Care Inc. | 16 |
| Merit Medical® | Merit Medical Systems, Inc. | 10 |
| Kew Medical | Douglas Medical Products, Inc | 8 |
| Merit Medical® | Argon Critical Care Systems Singapore PTE. Ltd. | 5 |
| CIV | Emed Technologies Corporation | 5 |
| Medrad® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube | Bayer Medical Care Inc. | 5 |
| Lifeshield | ICU Medical, Inc | 5 |
| EZ-IV | Emed Technologies Corporation | 5 |
Showing 12 of 51. All products under Tubing, Fluid Delivery
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K883718 | 1989-01-30 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-06-05 | Class II | Process control | High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient. | 8040 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.